A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer

Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study ID
NCT02131506
Phase
PHASE1
Status
Terminated

Conditions

  • HER-2 Positive Breast Cancer
  • Malignant Neoplasm of Breast

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib, Caelyx — DRUG
    Lapatinib, Caelix: Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq \& Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq \& Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq \& Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq \& Lapatinib 1500 mg die

Study Details

A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2 positive pretreated Breast Cancer. Treatment Plan: Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq \& Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq \& Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq \& Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq \& Lapatinib 1500 mg die. Three patients will be initially enrolled in each dose level starting from level 1. If none of the first triplet of patients will develop DLT, the dose will be escalated to the next level for the subsequent three patients. If one of the first triplets of patients will develop first-course DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is defined as the dose below that at which two patients have experienced DLT. Lapatinib will be self-administered by the patient in an outpatient setting at the dose of the assigned step. Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to guarantee a constant speed of infusion) on day 1 of each cycle repeated every 21 days. STATISTICAL METHODOLOGY: Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib. Evaluation of response: all patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible. All conclusions should be based on all eligible patients. Subanalyses may then be performed on the basis of a subset of patients, excluding those for whom major protocol deviations have been identified .However, these subanalyses may not serve as the basis for drawing conclusions concerning treatment efficacy, and the reasons for excluding patients from the analysis should be clearly reported. The 95% confidence intervals should also be provided.

Key Dates

Start date
Dec 31, 2009
Status verified
Feb 2016
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib, Caelyx
    * Lapatinib is given at escalating doses orally and continuously on days 1-21. * Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1.

Primary Outcome Measure

MTD (Maximum Tolerated Dose) [ Time Frame: 6 years ]

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